Home NDC 0904-7425 lurasidone hydrochloride
Product NDC 0904-7425
11-digit product format 009047425
Labeler code 0904
Product ID 0904-7425_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lurasidone hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler MAJOR PHARMACEUTICALS
Application ANDA208037
Marketing category ANDA
Marketing start 2023-02-09
Substance LURASIDONE HYDROCHLORIDE
Active strength 120 mg/1
Pharmacologic classes Atypical Antipsychotic [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208037-001 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 A208037-002 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 A208037-003 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 A208037-004 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 A208037-005 LURASIDONE HYDROCHLORIDE LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 4 · 135 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208037-001 LURASIDONE HYDROCHLORIDE 20MG TABLET / ORAL AB 2022-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208037-002 LURASIDONE HYDROCHLORIDE 40MG TABLET / ORAL AB 2022-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208037-003 LURASIDONE HYDROCHLORIDE 60MG TABLET / ORAL AB 2022-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208037-004 LURASIDONE HYDROCHLORIDE 80MG TABLET / ORAL AB 2022-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208037-005 LURASIDONE HYDROCHLORIDE 120MG TABLET / ORAL AB 2022-09-09 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 135 observed states.
Additional Listing Data#
Finished product Yes
Brand name base lurasidone hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LURASIDONE HYDROCHLORIDE 120 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O0P4I5851I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 5 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1040031 Internal RxNorm lookup 1040041 Internal RxNorm lookup 1235247 Internal RxNorm lookup 1297278 Internal RxNorm lookup 1431235 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0904-7425-46 lurasidone hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7425 LURASIDONE HYDROCHLORIDE TABLET, FILM COATED [MAJOR PHARMACEUTICALS] 1 Current NDC, 1 package rows 20240107_cecfd4c8-bff3-44fa-b360-b3e8a8e955f5.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0904-7425-46 00904742546 30 TABLET, FILM COATED in 1 BOTTLE (0904-7425-46) 2024-01-05 No No Current